An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *
KERENDIA® (finerenone) Meets Primary Endpoint in Phase III Clinical Trial for Adults with Type 1 Diabetes and Chronic Kidney Disease
On Nov. 6, Bayer announced new Phase III investigational data from the pivotal FINE-ONE trial showing that KERENDIA® (finerenone) significantly reduced urine albumin-to-creatinine ratio (UACR) from baseline over six months by 25% compared to placebo in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) who were receiving standard of care (95% CI=0.75 [0.65; 0.87]; p=0.0001).
These late-breaking data were presented at the opening plenary session of the American Society of Nephrology (ASN) Kidney Week 2025 in Houston by Dr. Hiddo Lambers Heerspink, Professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen, Netherlands, and Chair of the study’s Steering Committee.
“We are excited to announce the results of the FINE-ONE trial, which represents the first positive Phase III study in 30 years dedicated to patients with type 1 diabetes and chronic kidney disease — a research advancement underscored by the trial’s inclusion in the opening plenary session,” said Endocrine Society member Janet McGill, MD, MA, professor of medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine in St. Louis, and Co-Chair of the study’s Steering Committee. “By significantly reducing UACR—a key marker of cardiovascular risk and kidney damage—finerenone has the potential to become an important addition to the treatment landscape for patients with type 1 diabetes and chronic kidney disease.”
Up to 30% of Americans living with T1D are affected by CKD.
Since July 2021, KERENDIA has been approved to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure, non-fatal myocardial infarction (MI), sustained estimated glomerular filtration rate (eGFR) decline, and end-stage kidney disease in adult patients with CKD associated with type 2 diabetes (T2D). In July 2025, KERENDIA also received U.S. Food and Drug Administration (FDA) approval for the treatment of heart failure with left ventricular ejection fraction (HF LVEF) of ≥40%.7
FINE-ONE (FINErenone efficacy and safety in chronic kidney disease and type ONE diabetes; NCT05901831) is a pivotal, global, randomized, prospective, double-blind, multicenter, Phase III study in people with T1D and CKD. It enrolled 242 adult participants with the primary objective to demonstrate whether the addition of finerenone, 10 or 20 mg once daily, to standard of care is superior to placebo in reducing UACR over six months. The primary endpoint was the relative change in UACR from baseline over six months. UACR is being investigated as a bridging biomarker to demonstrate delayed kidney disease progression. Elevated UACR is strongly associated with CV risk and kidney disease progression in multiple patient populations, including T1D and T2D.8,9,10 Safety of finerenone was also assessed in the study. Finerenone is the first investigational treatment, since the 1990s, to show positive results in a Phase III study dedicated to people living with T1D and CKD and works by selectively and potently blocking mineralocorticoid receptor overactivation in the heart and kidneys.7
In FINE-ONE, safety and tolerability with finerenone were largely consistent with the existing evidence for people with T2D and CKD. The rate of treatment-emergent adverse events (TEAEs) was 47.1% for those treated with finerenone and 49.2% for placebo. The rate of treatment-emergent serious adverse events (TESAEs) was 11.8% and 11.5%, respectively. Hyperkalemia, an adverse event of special interest (AESI), was observed more frequently with finerenone (10.1%) compared to placebo (3.3%). The rate of treatment discontinuation due to hyperkalemia was 1.7% and 0%, respectively.
Bayer plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA based on the results of FINE-ONE in 2026.
Veracyte Announces First Publications Using Afirma GRID Research Tool To Help Usher in Next Generation of Thyroid Nodule Testing
On Nov. 3, –Veracyte, Inc. announced the publication of two studies demonstrating the Afirma GRID (Genomic Resource for Intelligent Discovery)research tool’s ability to help define the future of thyroid nodule evaluation. Using the company’s innovative whole-transcriptome-derived research-use-only platform, researchers analyzed molecular data from thyroid nodules to develop signatures with potential to provide enhanced prognostic information prior to surgery.
The first study describes the development and validation of mRNA-based classifiers to preoperatively predict low-risk thyroid tumor features in collaboration with researchers at Memorial Healthcare System in South Florida and Brigham and Women’s Hospital in Boston. The second study, published independently by researchers at Cleveland Clinic, explores whether mRNA-based expression signatures can be used to differentiate higher-risk tumors prior to surgery.
“We introduced Afirma GSC in 2017 to primarily help patients with indeterminate thyroid nodules—those that were not clearly benign or malignant—avoid unnecessary diagnostic surgery. Now, Veracyte is working to help clinical researchers better answer the next critical question for thyroid nodule care: ‘For those patients whose nodules are likely cancerous, how much surgery is needed?’ These studies, which evaluate biomarkers to determine a likely cancer’s aggressiveness, may one day enable us to answer this question,” said Endocrine Society member Joshua Klopper, MD, Veracyte’s medical director for Endocrinology.
In the Cleveland Clinic study, 445 thyroid samples had undergone Afirma GSC testing. Researchers then evaluated these samples using 30 molecular signatures available for research use only through the Afirma GRID to determine whether any could differentiate nodules, based on risk groups developed by the American Thyroid Association to categorize a thyroid nodule’s likelihood of being low or intermediate/high risk thyroid cancer. Two of the signatures stood out: an “invasion signature” for which a higher score predicted a 30% greater likelihood of intermediate- or high-risk cancer and a “NIS expression” signature for which higher expression levels predicted low-risk cancers.
Dr. Gustavo Romero-Velez, an endocrine surgeon at the Cleveland Clinic and senior author on the study, said, “The next phase in thyroid nodule care is to find a preoperative prognostic marker with clinical utility. Veracyte with Afirma GRID is giving us a path to do that work to get to a clinically useful prognostic marker.”
While the study does not yet provide the necessary data or validation for clinical use of these signatures, it highlights several with potential clinical utility. The study authors concluded that with further validation studies, gene expression profile signatures may serve as a preoperative predictive tool for high-risk features, potentially enhancing recurrence risk stratification and helping guide extent-of-surgery discussion with patients.
These publications demonstrate the power of Afirma GRID—enabling clinicians and scientists to explore molecular markers and signatures that may one day help guide patient treatment. Veracyte’s commitment to making Afirma GRID available for research is rapidly fueling the expansion of thyroid cancer insights.
About Afirma GRID
The Afirma GRID database is derived from the sequencing of over 21,000 expressed genes for over 200,000 patients with thyroid nodules (benign and malignant) and is used by Veracyte and its partners to contribute to continued research that helps advance understanding of thyroid tumors. Afirma GRID information is available on a Research-Use-Only basis. More information about Afirma GRID can be found here.
*Inclusion in Pharma Fridays does not suggest an endorsement by Endocrine News or the Endocrine Society.
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